Screening patients who meet the criteria for peripheral blood mononuclear cell (PBMC) isolation and cell preparation. Based on the status of cell preparation and mutual agreement between the researcher and the participant, the date of reinfusion (Day 0) is determined. From Day -5 to Day -3, the participant receives a conditioning regimen with cyclophosphamide and antithymocyte globulin. After recovery for two days (Day -2 and Day -1), on Day 0, the participant receives reinfusion of BZE2203 (dose determined according to the dose-escalation requirements). The safety observation period lasts for 28 days, and clinical efficacy is assessed from Day 28 to Day 34. After comprehensive judgment, the second course of cell therapy is selected. Follow-up observations and evaluations are conducted once every three months, with follow-up visits once a year and telephone follow-ups once every two months.
Patients with gynecological solid tumors diagnosed by histopathology, with tumor tissue sample MUC1 expression rate ≥50% or MSLN expression rate ≥50%, PD-L1 positive expression, and sample source within 2 years;
Patients with advanced gynecological solid tumors who have failed standard treatment or are intolerant to such treatment and have no standard effective treatment options;
Females aged 18 to 70 years (inclusive);
Estimated survival time ≥ 3 months;
Participants who have undergone other anti-tumor treatments not allowed by the protocol within 1 month before CAR-T infusion (including radiotherapy, chemotherapy, small molecules, biological treatment, or immunotherapy, other research drugs);
Participants who have previously received targeted therapy against MUC1 or MSLN, or cellular therapy, or any gene therapy products (including CAR-T cell therapy) or any T cell therapy at home or abroad;
Pregnant or breastfeeding women;
AIDS virus, syphilis seroreactivity positive; hepatitis B surface antigen positive, or hepatitis B core antibody positive and hepatitis B virus DNA copies higher than the detection limit or greater than or equal to 1000 copies/mL; or hepatitis C virus infection;
Single group
Cell therapy with bispecific antibodies
DrugThe dose-escalation phase is designed with three predefined dose levels, following a "3+3 design" and progressing from low to high doses. The "3+3" dose-escalation scheme is as follows: if no dose-limiting toxicity (DLT) occurs in the three subjects at a given dose level during the observation period, the dose will be escalated to the next higher level. If one subject out of the initial three experiences DLT at a dose level, an additional three subjects will be enrolled at that dose level for further DLT observation. The dose level at which no more than one subject out of the final six subjects experiences DLT will be defined as the maximum tolerated dose (MTD).
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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